scholarly journals Artificial Intelligence and Medical Negligence in Malaysia: Confronting the Informed Consent Dilemma

2021 ◽  
Vol 11 (11) ◽  
Author(s):  
Hartini Saripan ◽  
Nurus Sakinatul Fikriah Mohd Shith Putera ◽  
Rafizah Abu Hassan ◽  
Sarah Munirah Abdullah
Keyword(s):  
Artificial Intelligence ◽  
Informed Consent ◽  
Medical Negligence

scholarly journals Obligations, consent and contracts in Scots law: re-analysing the basis of medical malpractice liability in light of Montgomery v Lanarkshire Health Board

Legal Studies ◽  
2021 ◽  
pp. 1-21
Author(s):  
Jonathan Brown
Keyword(s):  
Informed Consent ◽  
Legal System ◽  
Medical Malpractice ◽  
Health Board ◽  
Medical Negligence ◽  
University Hospitals ◽  
Malpractice Liability ◽  
Patient Relationships ◽  
Physician Patient ◽  
Medical Regime

Abstract Professors MacQueen and Thomson have defined ‘contract’, within Scots law, as denoting ‘an agreement between two or more parties having the capacity to make it, in the form demanded by law, to perform, on one side or both, acts which are not trifling, indeterminate, impossible or illegal’. This definition reflects the fact that Scottish contracts are underpinned by consent, rather than by ‘consideration’. This, naturally, has the potential to be of great significance within the context of physician/patient relationships, particularly since the 2006 case of Dow v Tayside University Hospitals NHS Trust acknowledged that these relationships could be contractual in nature. This observation is of renewed importance since the landmark decision in Montgomery v Lanarkshire Health Board, which found that physicians must ensure that they obtain full and freely given ‘informed consent’ from their patients, prior to providing medical services. In light of the present medical regime which requires ‘doctor and patient [to] reach agreement on what should happen’, the basis of liability for medical negligence, in Scotland, requires reanalysis: ‘To have a contract only when the patient pays is not consistent with a legal system which has no doctrine of consideration in contract’.

scholarly journals 217 Cytotoxicity of nicotinamide enhanced natural killer cells GDA201 is based on metabolic modulation as demonstrated by artificial intelligence assisted analysis of NK cell transcriptome and metabolome

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A230-A230
Author(s):  
Dima Yackoubov ◽  
Aviad Pato ◽  
Julia Rifman ◽  
Sherri Cohen ◽  
Astar Hailu ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Machine Learning ◽  
Informed Consent ◽  
Nk Cells ◽  
Natural Killer ◽  
Cell Function ◽  
Nk Cell ◽  
Medical Center ◽  
Enzymatic Reactions ◽  
Combined Algorithm

BackgroundNicotinamide (NAM), an allosteric inhibitor of NAD-dependent enzymes, has been shown to preserve cell function and prevent differentiation in ex vivo cell culture. GDA-201 is an investigational natural killer (NK) cell immunotherapy derived from allogeneic donors and expanded using IL-15 and NAM. In previous preclinical studies, NAM led to increased homing and cytotoxicity, preserved proliferation, and enhanced tumor reduction of NK cells. In a phase I clinical trial, treatment with GDA-201 showed tolerability and clinical responses in patients with refractory non-Hodgkin lymphoma (NHL) (Bachanova, et. al., Blood 134:777, 2019). While NAM is known to affect cellular metabolism and participate in 510 enzymatic reactions −in 66 as an inhibitor or activator− its mechanism of action and role in GDA-201 cytotoxicity is unknown.MethodsIn order to define the network of intracellular interactions that leads to the GDA-201 phenotype, flow-cytometry, next generation sequencing (NGS), and liquid chromatography–mass spectrometry (LC-MS)-based metabolite quantification were performed on NK cells cultured for 14 days with IL-15 and human serum in the presence or absence of NAM (7 mM). Artificial Intelligence (AI) machine learning analysis was applied by Pomicell in order to analyze the data using the Pomicell databases supporting data extracted from multiple origins including scientific articles organized using natural language processing tools. AI training was done using a combined algorithm designed to blindly explain and predict the transcriptomic and metabolomic (omics) profile.ResultsOmics analyses defined 1,204 differentially expressed genes, and 100 significantly modified metabolites in the presence of NAM. An in silico model was created that successfully predicted the experimental data in 83% of the cases. Upregulation of TIM-3 expression in GDA-201 was predicted to be mediated by inhibition of IL-10 and SIRT3, via CREB1/HLA-G signaling and adrenoceptor beta 2 (ADRB2) upregulation. Adenosine metabolite reduction supports this and suggests dopaminergic activation of NK cytotoxicity. Upregulation of CD62L in the presence of NAM was predicted to be mediated by transcription factor Dp-1 (TFDP1) via dihydrofolate reductase (DHFR) activation and intracellular folic acid reduction. Interferon-gamma and CASP3 modulation (via JUN and MCL1, respectively), via PPARa inhibition, support that finding.ConclusionsIn conclusion, AI machine learning of transcriptome and metabolome data revealed multiple pleiotropic metabolic pathways modulated by NAM. These data serve to further elucidate the mechanism by which NAM enhances cell function, leading to the observed cytotoxicity and potency of GDA-201.Ethics ApprovalWe hereby declare that the collection of the Apheresis units in the three participating institutes (sites) has been done under an approved clinical study that meets the following requirements:1. Ethics approval has been obtained from the local EC at each of the sites, prior to any study related activities.2. The working procedures of the EC at the sites for conduct of clinical studies are in due compliance with local regulations (Israeli Ministry of Health) and provisions of Harmonized International Guidelines for Good Clinical Practice, namely: ICH-GCP.3. Sites follow EC conditions & requirements in terms of submissions, notifications, and approval renewals. 4. Participants gave Informed Consent (approved by the EC) before taking part in the study.5. Informed Consent has been approved by the ECs. The Israeli template of Informed Consent is in used and it includes study specific information (e.g. study goal, design, method, duration, risks, etc.). Name of the Institute Name of the EC/IRB EC Study No.Hadassah Medical Center Helsinki Committee 0483-16-HMORambam Health Care Campus Helsinki Committee 0641-18-RMBIchilov Sourasky Medical Center Tel-Aviv Helsinki Committee 0025-17-TLV

Digitized Future of Medicine: Challenges for Bioethics

2020 ◽  
Vol 63 (2) ◽  
pp. 83-103
Author(s):  
Elena G. Grebenshchikova ◽  
Pavel D. Tishchenko
Keyword(s):  
Artificial Intelligence ◽  
Phase Transitions ◽  
Informed Consent ◽  
Moral Responsibility ◽  
Personal Autonomy ◽  
Quantified Self ◽  
Human Beings ◽  
Ethics Of Responsibility ◽  
Biomedical Technologies ◽  
Uncertain Future

The article discusses the challenges, benefits, and risks that, from a bioethical perspective, arise because of the the development of eHealth projects. The conceptual framework of the research is based on H. Jonas’ principles of the ethics of responsibility and B.G. Yudin’s anthropological ideas on human beings as agents who constantly change their own boundaries in the “zone of phase transitions.” The article focuses on the events taking place in the zone of phase transitions between humans and machines in eHealth. It is shown that for innovative practices related to digitalization and datafication in medicine, it is needed to rethink central bioethical concepts of personal autonomy and informed consent. In particular, the concept of broad or open informed consent is discussed, which allows the idea of moral responsibility in the field of biomedical technologies to be extended to events of uncertain future. The authors draw attention to the problems associated with the emergence of new autonomous subjects/agents (machines with artificial intelligence) in relationship between doctors and patients. The humanization of machines occurring in eHealth is accompanied by a counter trend – the formation of conceptions and practices of the quantified self. There emerges the practices of self-care and bio-power (M. Foucault) caused by the datafication and digitization of personality. The authors conclude that bioethics should proactively develop norms for the evolving interaction between doctor and patients.

Nigerian laws on informed consent before a surgical procedure

2019 ◽  
Vol 87 (4) ◽  
pp. 185-187
Author(s):  
Mabel Ijeoma Ezeuko
Keyword(s):  
Informed Consent ◽  
Medical Ethics ◽  
National Health ◽  
Surgical Procedure ◽  
Medical Intervention ◽  
Medical Procedure ◽  
Medical Negligence ◽  
Medical Practitioners ◽  
National Health Act

Informed consent is a process of communication between a clinician and a patient, which results in the patient's agreement to undergo a medical procedure. Rule 19 Part A: Code of Medical Ethics of Nigeria and Section 23 of the National Health Act 2004 prescribe the process of obtaining consent before a medical intervention. The equitable law of torts and/or criminal liabilities that deal with medical negligence should be invoked more often by patients whose right to informed consent is denied by medical practitioners.

scholarly journals What Can Spine Surgeons Do to Improve Patient Care and Avoid Medical Negligence Suits?

2020 ◽  
Vol 11 ◽  
pp. 38
Author(s):  
Nancy E. Epstein
Keyword(s):  
Informed Consent ◽  
Patient Care ◽  
Postoperative Care ◽  
Surgical Complications ◽  
Improve Patient Care ◽  
Medical Personnel ◽  
Physiological Monitoring ◽  
Medical Negligence ◽  
Perioperative Morbidity ◽  
Improve Patient

Background: Why do patients sue following spine surgery? Here we reviewed some of the most frequent reasons for medical negligence suits against surgeons, adjunctive medical personnel, and or institutions/hospitals. Methods: Summarizing the multiple reasons for suits against spine surgeons, their colleagues/consultants, and hospitals should help surgeons identify the problems leading to suits, and improve patient care. Results: Several of the most common reasons for medical negligence suits include: lack of informed consent, ghost surgery, failure to diagnose and treat (e.g. including preoperative, perioperative, and post-surgical complications), performing unnecessarily risky, excessive and/or unnecessary surgery; failure to provide adequate postoperative care; absent or inadequate intraoperative neural physiological monitoring; and spoliation (e.g. fraudulent surgical, office, and/or hospital notes/records). Conclusions: There are many reasons why patients sue their spine surgeons. Being aware of the factors that lead to suits, spine surgeons should learn to provide better preoperative, intraoperative, and postoperative care, and, thus, limit perioperative morbidity and mortality.

scholarly journals Artificial inteligence and its use in the process of providing health care

2021 ◽  
pp. 91-112
Author(s):  
Sona Sopuchova
Keyword(s):  
Artificial Intelligence ◽  
Health Care ◽  
Informed Consent ◽  
Cyber Security ◽  
Slovak Republic ◽  
Medical Documentation ◽  
Health Care Provision ◽  
Private Communication ◽  
Remote Medicine ◽  
Remote Health

In the article, the author discusses the issue of electronic health care with a focus on telemedicine. The first part of the paper provides an overview and explanation of the basic related concepts, which are electronic healthcare and e-health, telemedicine and health care. In this part, the author also summarizes the relevant legislation. The author also presents the performance of telemedicine in the conditions of the Slovak Republic. Above all, the author asks which legal institutes are affected by another way of providing health care, which is distance medicine? The author gradually analyzes selected issues, namely instruction and informed consent, making audio or video-audio recording, recording telemedicine performance in medical documentation and payment for such performance. The conclusion of the article is devoted to summarizing and pointing out the threats and challenges of telemedicine, which the author considers the use of private communication platforms, the related violation of cyber security and the use of artificial intelligence. Key words: electronic healthcare, e-health, telemedicine, remote medicine, remote health care provision.

scholarly journals Diagnosing Diabetic Retinopathy With Artificial Intelligence: What Information Should Be Included to Ensure Ethical Informed Consent?

2021 ◽  
Vol 8 ◽  
Author(s):  
Frank Ursin ◽  
Cristian Timmermann ◽  
Marcin Orzechowski ◽  
Florian Steger
Keyword(s):  
Artificial Intelligence ◽  
Primary Care ◽  
Diabetic Retinopathy ◽  
Informed Consent ◽  
Care Setting ◽  
Primary Care Setting ◽  
Information Process ◽  
Novel Technologies ◽  
Ethical Implications ◽  
Aided Diagnosis

Purpose: The method of diagnosing diabetic retinopathy (DR) through artificial intelligence (AI)-based systems has been commercially available since 2018. This introduces new ethical challenges with regard to obtaining informed consent from patients. The purpose of this work is to develop a checklist of items to be disclosed when diagnosing DR with AI systems in a primary care setting.Methods: Two systematic literature searches were conducted in PubMed and Web of Science databases: a narrow search focusing on DR and a broad search on general issues of AI-based diagnosis. An ethics content analysis was conducted inductively to extract two features of included publications: (1) novel information content for AI-aided diagnosis and (2) the ethical justification for its disclosure.Results: The narrow search yielded n = 537 records of which n = 4 met the inclusion criteria. The information process was scarcely addressed for primary care setting. The broad search yielded n = 60 records of which n = 11 were included. In total, eight novel elements were identified to be included in the information process for ethical reasons, all of which stem from the technical specifics of medical AI.Conclusions: Implications for the general practitioner are two-fold: First, doctors need to be better informed about the ethical implications of novel technologies and must understand them to properly inform patients. Second, patient's overconfidence or fears can be countered by communicating the risks, limitations, and potential benefits of diagnostic AI systems. If patients accept and are aware of the limitations of AI-aided diagnosis, they increase their chances of being diagnosed and treated in time.

Digitized Future of Medicine: Challenges for Bioethics

2020 ◽  
Vol 63 (2) ◽  
pp. 83-103
Author(s):  
Elena G. Grebenshchikova ◽  
Pavel D. Tishchenko
Keyword(s):  
Artificial Intelligence ◽  
Phase Transitions ◽  
Informed Consent ◽  
Moral Responsibility ◽  
Personal Autonomy ◽  
Quantified Self ◽  
Human Beings ◽  
Ethics Of Responsibility ◽  
Biomedical Technologies ◽  
Uncertain Future

The article discusses the challenges, benefits, and risks that, from a bioethical perspective, arise because of the the development of eHealth projects. The conceptual framework of the research is based on H. Jonas’ principles of the ethics of responsibility and B.G. Yudin’s anthropological ideas on human beings as agents who constantly change their own boundaries in the “zone of phase transitions.” The article focuses on the events taking place in the zone of phase transitions between humans and machines in eHealth. It is shown that for innovative practices related to digitalization and datafication in medicine, it is needed to rethink central bioethical concepts of personal autonomy and informed consent. In particular, the concept of broad or open informed consent is discussed, which allows the idea of moral responsibility in the field of biomedical technologies to be extended to events of uncertain future. The authors draw attention to the problems associated with the emergence of new autonomous subjects/agents (machines with artificial intelligence) in relationship between doctors and patients. The humanization of machines occurring in eHealth is accompanied by a counter trend – the formation of conceptions and practices of the quantified self. There emerges the practices of self-care and bio-power (M. Foucault) caused by the datafication and digitization of personality. The authors conclude that bioethics should proactively develop norms for the evolving interaction between doctor and patients.

Medical negligence and informed consent: an overview

2011 ◽  
Vol 29 (2) ◽  
pp. 97-100 ◽  
Author(s):  
Sebastian Dawson-Bowling
Keyword(s):  
Informed Consent ◽  
Medical Negligence
Sign in / Sign up

Export Citation Format

Share Document